Model Number 3100 A |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/26/2024 |
Event Type
malfunction
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Event Description
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It was reported to vyaire medical that audible internal leak when device is connected to gas sources occurred on the 3100 a device.The customer reported there was no patient involvement associated with the reported event.
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Manufacturer Narrative
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Vyaire medical file identification: (b)(4).H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device not returned yet.
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Manufacturer Narrative
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Results of investigation: vyaire medical field service technician went onsite to evaluate the device.Technician took off all the covers then plugged in the gas sources.Fsr found that the unit was leaking from the air filter/connection point to the unit.Tightened the connection points and reseeded the air filter housing.Unit is no longer leaking.Ran the unit through a 2k to adjust and or calibrate any needed parts.Unit is confirmed working correctly and is ready for patient usage.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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